Clinical trial · Observational
Home Away From Home - Medical Outcomes
Home or Away From Home: Comparing Clinical Outcomes Relevant to the Care of Pediatric Acute Myeloid Leukemia During Periods of Neutropenia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Treatment for pediatric acute myeloid leukemia (AML) involves intensive chemotherapy regimens that result in periods of profound neutropenia leaving patients susceptible to severe infectious complications. Infectious complications are the leading cause of treatment related mortality among AML patients, but there are little clinical data to inform whether management of neutropenia post AML chemotherapy should occur in an outpatient or inpatient setting. The primary objective of this study is to compare the clinical effectiveness of outpatient versus inpatient management of neutropenia in children with AML.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Bacteremia | — | UNRESOLVED | — |
| Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Early Discharge Management
- description
- Discharge to outpatient management during neutropenia within 3 days after chemotherapy completion in a given course
- label
- Inpatient Management
- description
- Remain hospitalized during chemotherapy-induced neutropenia
Primary outcomes (1)
- measure
- Occurrence of Post-chemotherapy Bacteremia
- timeFrame
- Identification of bacteremia will begin three days after completion of a chemotherapy course and will continue until recovery of absolute neutrophil count (ANC > 200 uL), or until the start of the next course.
- description
- Identification of bacteremia will begin three days after completion of a chemotherapy course and will continue until recovery of absolute neutrophil count (ANC \> 200 uL), or until the start of the next course (for a very small number of patients who begin the next course of chemotherapy prior to count recovery). Bacteremia will be defined as a single positive blood culture for a bacterial pathogen (including Viridans group Streptococci). If the bacterium is an organism considered as a common commensal organism by the National Healthcare Safety Network, two separate positive blood cultures will be required for classification as bacteremia.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Males or females of age less than 19 at diagnosis. 2. Receipt or planned receipt of AML chemotherapy between January 1, 2012 and December 31, 2019. Exclusion Criteria: 1. Patients being treated for relapsed AML 2. Patients with Acute Promyelocytic Leukemia (APML) 3. Patients undergoing stem cell transplant (SCT) 4. Patients receiving reduced intensity frontline chemotherapy
References
Publications (0)
Data not yet available